Daratumumab Medicine 12 June 2018 Extended indication Extension of indication to extend the existing therapeutic indication for daratumumab in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). Therapeutic value No judgement Total cost € 5,270,000.00 Registration phase Registration application pending Product Active substance Daratumumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Multiple Myeloma Extended indication Extension of indication to extend the existing therapeutic indication for daratumumab in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). Current proprietary name Already available biosimilars / generics Proprietary name Darzalex Manufacturer Janssen Portfolio holder Mechanism of action Immunostimulation Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Antilichaam tegen CD38. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date May 2019 Expected Registration March 2020 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Deze daratumumab indicatie valt niet onder het huidige financieel arrangement. Deze indicatie is in de sluis geplaatst aangezien daratumumab breed uitgesloten is van opname in het verzekerde pakket. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Cassiopeia trial met primary endpoint Duration of treatment Frequency of administration 1 times every 8 weeks Dosage per administration 16 mg/kg References NCT02541383 Additional remarks 16mg/kg every 8 weeks for 2 years. Expected patient volume per year Patient volume < 155 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Pakketadvies daratumumab (Darzalex®) bij multipel myeloom, ZIN 2017 Additional remarks Jaarlijks aantal nieuwe multipel myeloma patiënten bedraagt 1.117, waarvan 90% symptomatisch: 1006. Patiënten <70 jaar zonder co-morbiditeiten bedraagt 50%. 95% wordt behandeld (387). Hiervan zal naar verwachting 40% een VTD-ASCT ondergaan, dit betekent dat 155 patiënten in aanmerking komen. Hoeveel patiënten hiervan daadwerkelijk met daratumumab zullen worden behandeld moet nog vastgesteld worden. Expected cost per patient per year Cost € 34,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Medicijnkosten.nl Additional remarks Flacon 100 mg kost €431,36. Uitgegaan van een patiënt van 70 kg en behandelduur van een jaar. Deze daratumumab indicatie valt niet onder het huidige financieel arrangement. Deze indicatie is in de sluis geplaatst tot dat er een financieel arrangement is overeengekomen. Potential total cost per year Total cost € 5,270,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions References Additional remarks Other information Additional remarks